A Minimum Protocol for Randomised Homeopathic Drug Proving as Basis for Further Research

Abstract

Background: In order to further improve the methodology and quality of data collection in homeopathic drug provings (HDP), there is a need for a minimum standardised HDP protocol. The objective of the present study was to test the feasibility of this type of protocol. Materials and Methods: The study protocol embraced a multi-centre, randomised, double-blind, placebo-controlled trial with 2 parallel groups. It was approved by an ethics review committee. During the pre-approval phase, discordances between the regulatory and homeopathic requirements for the protocol were checked and solutions found. The study medication was Potentilla anserina. 6 participants received verum and 4 placebo. The resulting symptom list will be published elsewhere. The procedure was accepted by all participants. Results: Three important issues were addressed: the requirement to keep all participants blinded; the adverse events reporting to regulatory authorities; and the necessity of a placebo control group. Other issues that need further investigations were identified, e.g. sample size, observation period and dosage regimen. Conclusions: A minimum protocol of a HDP is feasible. All important design elements of HDP could be solved in discussions with the respective regulatory authorities, and participating homeopaths accepted the procedure.

Scientific proving of ultra high dilutions on humans

“…Recently the homeopathic community has harmonized national homeopathic drug proving guidelines and developed an international standard. 24 Inclusion of our innovative qualitative methods could help to identify specific responses. We tried to get funding for follow-up studies following this concept, but did not succeed.…”

Die Zukunft der Homöopathie

“…Das zeigen Meta-Analysen placebokontrollierter klinischer Studien [4,5,6]. Und das zeigt sich sowohl in unseren eigenen Arzneimittel-Prüfungen [7], die im Übrigen den erst neuerdings entwickelten Standards gut entsprechen [8], als auch in neueren Prüfungen [9]. Auch in Tierexperimenten [10,11,12,13] und in Pflanzenstudien [14,15,16] treten Effekte in solcher Häufigkeit auf.…”